An Analysis of the Regulatory and Legal Aspects of Patient Package Inserts

Joseph G. Valentino

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1976 21 U.S.C. § 321 (m) 21 C.F.R. § 310.501 Weibart, 1977, Potential distribution problems—1, Drug Inf. J., 11, 455 1951, United States v 8 Cartons, containing “Plantation ‘The Original,’ ”, 103 1948, Kordel v United States, Sup. Ct., 69, 106 Ibid, at. , 110 1948, United States v Urbeteit, Sup. Ct., 69, 112 1968, United States v An Article of Device, Diapulse Manufacturing Corporation of America, Sup. Ct, 389, 2059 e.g., W.A.C. 360-16-250 21 U.S.C. § 331 (k) 1969, The Founding Church of Scientology of Washington v United States, 409, 1146 21 C.F.R. § 310.501 (6) 21 U.S.C. § 353 (2) 21 U.S.C. § 352 (f) (1) 21 U.S.C. § 352 (f) (2) 21 U.S.C. § 321 (n) 21 U.S.C. § 331 (k) W.A.C. 360-16-250; N.J.A.C. 13:39-6.3 21 C.F.R. 201 .100 1977, Food and Drug Administration, Compliance Policy Guides, Guide, 7132, 28 1976, Fed. Reg., 41, 43108 1975, Fed. Reg., 40, 15392 1961, HEW Memo No. DAO #5, from Division of Advisory Opinions to Directors of Districts, 7 1975, Fed. Reg., 40, 15392 21 U.S.C. § 355 1976, Fed. Reg., 41, 43108 1976, Food and Drug Administration, Compliance Policy Guides, Guide, 7132, 09 1976, Fed. Reg., 41, 43108 1974, C.F.R., 21, 310 1976, 530, 1054